EUCTR2017-000438-79-HU进行中（未招募）1 期
Open label, prospective, exploratory study to investigate the effect of inhaled CHF5993 pMDI on central and peripheral airway dimensions in COPD patients by Functional Respiratory Imaging
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subject’s written informed consent obtained prior to any study-related procedure.
- •2. Male or Female COPD patients aged = 40 years.
- •3. Smoking history: of at least 10 pack-years
- •4. Smoking status: current or ex-smokers. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to screening visit.
- •If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to study entry.
- •5. Patients with documented COPD at least 12 months according to GOLD 2017.
- •6. Post-bronchodilator (BD) decreased Tiffeneau index: FEV1/FVC < 0.70.
- •7. Patients who present post- BD FEV1 less than 50 % of predicted.
- •8. Patients who present (Functional residual capacity) FRC =120% predicted.
- •9. Patients who present CAT assessment =10.
- •10. Patients on stable respiratory medications for at least 3 months prior to screening with non extrafine extemporary triple combination.
- •11. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 (extremes included) at the screening visit.
- •12. Ability to understand the study procedures and the risks involved and ability to be trained with DPI and pMDI training inhalers to use the devices correctly.
- •13. WOCBP fulfilling one of the following criteria:
- •a. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or
- •b. WOCBP with non-fertile male partners (contraception is not required in this case).
- •14. Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Pregnant or lactating women.
- •2. Patients with history or current diagnosis of asthma.
- •3. Medical history or current diagnosis of allergic rhinitis or atopy
- •4. Patients requiring use of the following medications:
- •a. Systemic steroids for COPD exacerbation in the 4 weeks
- •prior to screening;
- •b. Patients with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and or antibiotics or need for hospitalization
- •within 6 weeks prior to screening]
- •c. A course of antibiotics for COPD exacerbation longer
- •than 7 days in the 4 weeks prior to screening;
- •d. c-Phosphodiesterase-4 (PDE-4) inhibitors in the 4 weeks
- •prior to screening;
- •e. Use of antibiotics for a lower respiratory tract infection
- •(e.g. pneumonia) in the 4 weeks prior to screening;
- •5. Patients treated with non-cardio-selective ß-blockers in the week
- •prior screening.
- •6. Patients treated with long-acting anti-histamines unless taken at
- •stable regimen at least 2 months prior to screening and to be
- •maintained constant during the study.
- •7. Patients requiring long term (at least 12 hours daily) oxygen therapy
- •for chronic hypoxemia.7.Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
- •8.Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator’s judgment.
- •9.Lung cancer or history of lung cancer
- •10.Lung resection: subjects with a history of lung volume resection.
- •11.Subjects who have cardiovascular condition such as, but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator’s judgment
- •12.ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the patients at risk.
- •13.Medical history or current diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would have prevented use of anticholinergic agents.
- •14.History of hypersensitivity to M3 antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impacted the efficacy of the study treatment according to the Investigator’s judgment.
- •15.Clinical Significant laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to Investigator’s judgment.
- •16.Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L).
- •17.Unstable concurrent disease which may impact the feasibility of the results of the study according to Investigator’s judgment.
- •18.History of
研究者
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